FDA Orange Book · active-ingredient family
Ziprasidone hydrochloride
Ziprasidone hydrochloride is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GEODON · NDA 020825
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GEODONRLD×4 | VIATRIS | NDA 020825 | AB | Feb 05, 2001 | |
| GEODON | PFIZER INC | NDA 021483 | — | Mar 29, 2006 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZIPRASIDONE HYDROCHLORIDE×4 | ZYDUS LIFESCIENCES | ANDA 208988 | AB | Aug 22, 2017 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | MACLEODS PHARMS LTD | ANDA 204375 | AB | Feb 17, 2017 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | AUROBINDO PHARMA | ANDA 204117 | AB | Dec 27, 2016 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | MYLAN | ANDA 202395 | — | Oct 10, 2013 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | CHARTWELL RX | ANDA 090348 | AB | Sep 05, 2012 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | SANDOZ INC | ANDA 077562 | AB | Jun 01, 2012 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | APOTEX | ANDA 077561 | AB | Mar 02, 2012 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | DR REDDYS LABS INC | ANDA 077565 | AB | Mar 02, 2012 | |
| ZIPRASIDONE HYDROCHLORIDE×4 | LUPIN PHARMS | ANDA 077560 | — | Mar 02, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ziprasidone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
